| CTRI Number |
CTRI/2022/06/043190 [Registered on: 13/06/2022] Trial Registered Prospectively |
| Last Modified On: |
11/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparative evaluation of pain relieving effects of 2 doses of Dexamethasone given along with Bupivacaine during surgery |
|
Scientific Title of Study
|
Comparison of analgesic effect of different doses of Dexamethasone as an adjuvant to Bupivacaine in ultrasound guided supraclavicular brachial plexus block. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anshil Bhatia |
| Designation |
PG 2 year |
| Affiliation |
School of medical sciences and research |
| Address |
Department of Anesthesiology
Sharda University, knowledge park-|||
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9896618924 |
| Fax |
|
| Email |
Anshil.bhatia@sharda.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr UC Verma |
| Designation |
professor and Head of department of anesthesiology |
| Affiliation |
School of medical sciences and research |
| Address |
Department of Anesthesiology,
Sharda University, knowledge park-lll
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9868378740 |
| Fax |
|
| Email |
uttam.verma@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Anshil Bhatia |
| Designation |
PG 2 year |
| Affiliation |
School of medical sciences and research |
| Address |
Department of Anaesthesiology
Sharda University, knowledge park-lll
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9896618924 |
| Fax |
|
| Email |
Anshil.bhatia@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
| School of medical sciences and research, Greater Noida |
|
|
Primary Sponsor
|
| Name |
School of medical sciences and research |
| Address |
Sharda University, knowledge park-lll |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Anshil Bhatia |
OT Complex, Sharda Hospital |
Sharda Hospital, SMSR, Greater Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9896618924
Anshil.bhatia@sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
group B |
this group contains only Bupivacaine 0.5% 20 ml + 2ml NS.
Frequency of administration - once
Route of administration - supraclavicular brachial plexus block
Total duration of intervention- total 30 mins
10mins for block administration and 2 mins for assessment of effect of block
Then at 6hr, 9hr, 12hr and 24hrs postoperative monitoring to assess the effect on postop analgesia |
| Comparator Agent |
Group D4 |
this group contains Dexamethasone 4 mg 1ml + 1ml NS with Bupivacaine 0.5% 20 ml
Frequency of administration - once
Route of administration - supraclavicular brachial plexus block
Total duration of intervention- total 30 mins
10mins for block administration and 2 mins for assessment of effect of block
Then at 6hr, 9hr, 12hr and 24hrs postoperative monitoring to assess the effect on postop analgesia |
| Comparator Agent |
group D8 |
this group contains Dexamethasone 8 mg 2 ml with Bupivacaine 0.5% 20 ml.
Frequency of administration - once
Route of administration - supraclavicular brachial plexus block
Total duration of intervention- total 30 mins
10mins for block administration and 2 mins for assessment of effect of block
Then at 6hr, 9hr, 12hr and 24hrs postoperative monitoring to assess the effect on postop analgesia |
| Intervention |
there are three groups |
group D4, B and D8 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 & 2
Ortho upper limb surgeries |
|
| ExclusionCriteria |
| Details |
Patient refusal to participate in study.
History of allergy to local anesthetic and Dexamethasone.
History of usage of corticosteroids, opioids and any other analgesics.
Infection at the site of injection.
Pregnant females.
Coagulopathy or bleeding diathesis.
Significant cognitive or psychiatric history.
History of endocrine disease- Diabetes mellitus and thyroid disease
History of CNS, cardiovascular and renal disease. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the duration of analgesic effect with two different doses Dexamethasone (8mg Vs 4 mg) as an adjuvant to Bupivacaine in supraclavicular brachial plexus block. |
assessment of pain will be done till 20 mins just after giving the block and then in postoperatively at 6 hrs,9 hrs, 12hrs and 24hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the time required with respect to achieve:
complete onset of sensory block
complete onset of motor block
(2) To observe the incidence of complications in 3 different groups.
|
Assessment of duration of analgesia till 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
13/06/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Comparison of analgesic effect of different doses of Dexamethasone as an adjuvant to Bupivacaine in ultrasound guided supraclavicular brachial plexus block. Aim: To compare the analgesic effect of Dexamethasone 8mg Vs 4mg as an adjuvant to Bupivacaine in ultrasound guided Supraclavicular brachial plexus block. Study design: Prospective, observational, randomised comparative double blinded study. Materials and Methods: thirty six patients will be divided into three groups, 12 patients each. Group D8 will receive bupivacaine 0.5% 20 mL + dexamethasone 8mg 2 mL, group D4 will receive Bupivacaine 0.5% 20 ml + dexamethasone 4mg 1ml+ 1ml NS and group B will receive 20 ml Bupivacaine + 2ml NS. We will compare the onset of sensory and motor blocks, duration of analgesia and incidence of complications. |